消息面上，康宁杰瑞制药公布，JSKN003已获美国食品药品监督管理局(FDA)授予突破性疗法认定，用 于治疗既往接受过贝伐珠单抗治疗的晚期或转移性人表皮生长因子受体2有表达(IHC1+、2+和3+)铂耐 药复发性上皮性卵巢癌、原发性腹膜癌或输卵管癌成年患者。 康宁杰瑞制药-B(09966)午前涨超6%，截至发稿，涨6.05%，报11.57港元，成交额1283.17万港元。 国金证券发布研报称，JSKN003为公司自研HER2双抗ADC，该产品针对多适应症的III期临床试验在中 国有序推进：在铂类耐药卵巢癌全人群适应症中，其疗效与安全性已展现出优于Enhertu的特征，预计 2027年完成数据读出并报产；预计2026年向CDE提交2L HER2阳性乳腺癌的NDA；2025年10月启动中 国HER2阳性转移性结直肠癌适应症III期临床，该行预期JSKN003预期27/28/29年销售分成为 0.05/0.57/1.08亿元。 ...

Group 1 - The company is a pioneer in antibody technology in China, focusing on the research, production, and commercialization of innovative biopharmaceuticals for oncology, with a core technology platform that includes self-developed bispecific antibodies and ADC technology [2] - The global first PD-L1 subcutaneous injection KN035 was approved for market in November 2021, with expected sales and royalties of 130 million, 128 million, and 125 million yuan for 2025, 2026, and 2027 respectively [2] - The self-developed HER2 bispecific antibody KN026 has shown strong positive efficacy in treating 2L+ HER2-positive gastric cancer, with its application for market approval expected to be accepted by NMPA in September 2025, and anticipated approval in the second half of 2026 [2] Group 2 - JSKN003, a self-developed HER2 bispecific antibody ADC, is advancing in clinical trials for multiple indications in China, showing superior efficacy and safety compared to Enhertu, with data readout expected in 2027 [3] - The company plans to submit an NDA for 2L HER2-positive breast cancer in 2026 and will initiate a Phase III trial for HER2-positive metastatic colorectal cancer in October 2025, with projected sales of 0.05 million, 0.57 million, and 1.08 million yuan for 2027, 2028, and 2029 respectively [3] Group 3 - The company has established a diversified bispecific antibody ADC product matrix through its proprietary glycosylation site-specific conjugation technology platform and differentiated target layout strategy [4] - JSKN016 is the world's first TROP2/HER3 bispecific antibody ADC, currently enrolling over 400 patients for indications in lung and breast cancer, indicating a broad market potential [4] - JSKN022, a first-in-class targeted PD-L1/ITGB6 bispecific antibody ADC, initiated its first patient dosing in October, while JSKN027, which has a triple mechanism of action, is expected to file for IND soon [4]

Group 1 - The core viewpoint of the report is that the company, Corning Jereh Pharmaceutical-B (09966), is projected to experience a significant decline in revenue in 2025, followed by a recovery in the subsequent years, with expected revenues of 4.43 billion, 4.86 billion, and 5.50 billion in 2025, 2026, and 2027 respectively, reflecting a year-on-year change of -30.87%, +9.78%, and +13.22% [1] - The company is recognized as a pioneer in domestic antibody technology, with its HER2 bispecific antibody expected to receive approval soon, focusing on the research, production, and commercialization of innovative biopharmaceuticals in the oncology field [1] - The company’s self-developed PD-L1 subcutaneous injection KN035 was approved for market in November 2021, with projected sales and royalties of 1.3 billion, 1.28 billion, and 1.25 billion for the years 2025, 2026, and 2027 respectively [1] Group 2 - JSKN003, a self-developed HER2 bispecific antibody ADC, is advancing through clinical trials in China, showing superior efficacy and safety compared to Enhertu in platinum-resistant ovarian cancer, with data readout expected in 2027 and NDA submission planned for 2026 for 2L HER2-positive breast cancer [2] - The company is leveraging its proprietary glycosylation site-specific conjugation technology platform and a differentiated target layout strategy to build a diverse product matrix of bispecific antibody ADCs, including JSKN016, the world's first TROP2/HER3 bispecific antibody ADC, which has enrolled over 400 patients in lung and breast cancer indications [3] - JSKN022, a first-in-class targeted PD-L1/ITGB6 bispecific antibody ADC, has initiated patient dosing, while JSKN027, which possesses cytotoxic, anti-angiogenic, and immune-regulatory mechanisms, is expected to file for IND soon [3]

Core Viewpoint - Corning Jereh Pharmaceutical-B (09966) has seen a nearly 5% increase in stock price, attributed to the announcement of FDA granting Breakthrough Therapy Designation (BTD) for JSKN003, a treatment for specific types of ovarian cancer in patients previously treated with bevacizumab [1][1][1] Group 1: Company Developments - JSKN003 has received BTD from the FDA for treating platinum-resistant recurrent epithelial ovarian cancer, primary peritoneal cancer, or fallopian tube cancer in adults who have previously undergone bevacizumab treatment [1][1] - Prior to this, JSKN003 was approved by the FDA to conduct a Phase II clinical trial for treating PROC regardless of HER2 expression levels [1][1] - The drug has also received BTD from the National Medical Products Administration (NMPA) for PROC and colorectal cancer (CRC), as well as Fast Track designation and orphan drug status from the FDA for gastric/gastroesophageal junction cancer (GC/GEJ) [1][1][1] Group 2: Market Reaction - Following the announcement, Corning Jereh Pharmaceutical-B's stock price rose by 4.87%, reaching HKD 11.19, with a trading volume of HKD 8.53 million [1][1]

Core Viewpoint - Corning Jereh Pharmaceutical-B (09966) experienced a nearly 5% increase in stock price, reaching HKD 11.19 with a trading volume of HKD 8.53 million, following the announcement of breakthrough therapy designation (BTD) for JSKN003 by the FDA [1] Group 1: FDA Designation - JSKN003 has been granted breakthrough therapy designation (BTD) by the FDA for the treatment of platinum-resistant recurrent epithelial ovarian cancer, primary peritoneal cancer, or fallopian tube cancer (collectively referred to as "PROC") in adult patients who have previously received bevacizumab treatment [1] - Prior to this, JSKN003 had already received FDA approval to conduct a Phase II clinical trial for PROC regardless of HER2 expression levels, and it has also been granted BTD by the National Medical Products Administration (NMPA) for both PROC and colorectal cancer (CRC) [1] - The BTD designation further underscores the confidence of international regulatory agencies in the clinical potential of JSKN003 and its significance as a novel therapeutic candidate [1]

12月18日，受美股科技股集体下挫影响，港股今日维持低位震荡走势，截止收盘，恒生指数涨0.12%报 25498.13点，恒生科技指数跌0.73%报5418.29点，国企指数跌0.02%报8841.51点，红筹指数跌0.26%报 4049.62点。 盘面上，大型科技股走势分化，阿里巴巴跌1.3%，京东集团跌0.09%，小米集团跌2.47%，网易涨 0.67%，美团涨0.1%，快手涨0.23%，哔哩哔哩涨0.26%；航空股延续涨势，东方航空涨超7%；煤炭股 午后走强，汇力资源涨超9%；锂电池股跌幅居前，宁德时代跌超3%；新消费概念股走弱，名创优品跌 超3%；其他股票中，舜宇光学科技跌超1%；曹操出行跌超12%，恒大物业跌超9%，中国中免跌超 5%；上海复旦涨超7%，招金矿业涨超6%。 企业新闻 远大医药(00512.HK)：自主研发的重磅全球创新放射性核素偶联药物 GPN01530 在美国获批开展临床研 究。 和谐汽车(03836.HK)：附属iCar Group Limited可能通过引入新投资者开展进一步股权融资，涉资4000万 美元。 中国中车(01766.HK)：集团及下属企业近三个月合计签订约533.1 ...

此前，JSKN003已获FDA批准开展一项治疗不限HER2表达水平的PROC的II期临床试验，且分別在 PROC和结肠直肠癌(CRC)上获国家药监局药品审评中心授予BTD，在PROC上获FDA授予快速通道资格 认定并在胃╱胃食管结合部癌(GC/GEJ)上获FDA授予孤儿药资格认定。 本文源自：财华网 【财华社讯】康宁杰瑞制药-B(09966.HK)午后一度涨逾7%，截至发稿，涨4.5%，报10.69港元。消息面 上，该公司午间公布，JSKN003已获美国食品药品监督管理局("FDA")授予突破性疗法认定("BTD")，用 于治疗既往接受过贝伐珠单抗治疗的晚期或转移性人表皮生长因子受体2("HER2")有表达(IHC1+、2+和 3+)铂耐药复发性上皮性卵巢癌、原发性腹膜癌或输卵管癌(统称为"PROC")成年患者。 ...

Core Viewpoint - Corning Jereh Pharmaceutical-B (09966) has received Breakthrough Therapy Designation (BTD) from the FDA for JSKN003, aimed at treating platinum-resistant recurrent epithelial ovarian cancer, primary peritoneal cancer, or fallopian tube cancer in adult patients previously treated with bevacizumab [1][2] Group 1: Drug Development and Regulatory Approvals - JSKN003 has previously been approved by the FDA to conduct a Phase II clinical trial for treating PROC regardless of HER2 expression levels [1] - The drug has also received BTD from the National Medical Products Administration (NMPA) in China for both PROC and colorectal cancer (CRC) [1] - JSKN003 has been granted Fast Track designation by the FDA for PROC and orphan drug designation for gastric/gastroesophageal junction cancer (GC/GEJ) [1] Group 2: Clinical Need and Market Potential - Ovarian cancer is one of the most common malignant tumors of the female reproductive system, with most patients diagnosed at an advanced stage and a high recurrence rate [2] - Current treatment options for PROC patients are limited, with existing non-platinum single-agent chemotherapy regimens showing an overall response rate (ORR) of only 10% to 15% and a median progression-free survival of approximately 3 to 4 months [2] - The median overall survival for these patients is about 12 months, highlighting a significant unmet clinical need [2] - The company believes that the BTD designation will accelerate the clinical development and regulatory review process for JSKN003, providing new treatment options for global PROC patients [2]

Group 1 - Corning Jereh Pharmaceutical-B (09966) announced that JSKN003 has received Breakthrough Therapy Designation (BTD) from the FDA for the treatment of platinum-resistant recurrent epithelial ovarian cancer, primary peritoneal cancer, or fallopian tube cancer (collectively referred to as "PROC") in adult patients previously treated with bevacizumab [1] - JSKN003 has previously been granted FDA approval to conduct a Phase II clinical trial for PROC regardless of HER2 expression levels, and has also received BTD from the National Medical Products Administration (NMPA) for PROC and colorectal cancer (CRC) [1] - The BTD designation further underscores the confidence of international regulatory agencies in the clinical potential of JSKN003 as a novel therapeutic candidate [1] Group 2 - Ovarian cancer is one of the most common malignant tumors of the female reproductive system, with most patients diagnosed at an advanced stage, high recurrence rates, and poor prognosis [2] - For PROC patients, treatment options are limited, with existing non-platinum single-agent chemotherapy regimens showing an overall response rate (ORR) of only 10% to 15%, a median progression-free survival of approximately 3 to 4 months, and a median overall survival of about 12 months, highlighting a significant unmet clinical need [2] - The company believes that the BTD designation will further accelerate the clinical development and regulatory review process for JSKN003, providing new treatment options for PROC patients globally [2]

Group 1 - Corning Jereh Pharmaceutical-B (09966.HK) announced that JSKN003 has received Breakthrough Therapy Designation (BTD) from the U.S. Food and Drug Administration (FDA) for the treatment of platinum-resistant recurrent epithelial ovarian cancer, primary peritoneal cancer, or fallopian tube cancer (collectively referred to as PROC) in adult patients previously treated with bevacizumab [1] - JSKN003 has previously received FDA approval to conduct a Phase II clinical trial for PROC regardless of HER2 expression levels, and has also been granted BTD by the National Medical Products Administration (NMPA) in China for both PROC and colorectal cancer (CRC) [1] - The BTD designation further underscores the confidence of international regulatory agencies in the clinical potential of JSKN003 and its significance as a novel therapeutic candidate [1] Group 2 - Ovarian cancer is one of the most common malignant tumors of the female reproductive system, with most patients diagnosed at an advanced stage, high recurrence rates, and poor prognosis [2] - For PROC patients, treatment options are limited, with existing non-platinum single-agent chemotherapy regimens showing an overall response rate (ORR) of only 10% to 15%, a median progression-free survival of approximately 3 to 4 months, and a median overall survival of about 12 months, highlighting a significant unmet clinical need [2] - The company believes that the BTD designation will further accelerate the clinical development and regulatory review process for JSKN003, providing new treatment options for PROC patients globally [2]